India denies Novartis patent protection on cancer drug

India's Supreme Court ended a seven-year legal battle Monday by rejecting Swiss giant Novartis' bid for patent protection on a new version of its Glivec cancer pill in a ruling hailed by activists seeking access to cheaper generic drugs.

India’s top court on Monday rejected Swiss drug maker Novartis AG’s plea for patent protection of its cancer drug Glivec, in a landmark decision likely to bolster Indian pharmaceutical firms over foreign rivals and protect access to cheap generics in developing nations.

The court’s move sets a legal precedent that appears to look unfavourably on putting new patents on existing drugs sold in India, a move which poses challenges for foreign firms in ongoing intellectual property disputes in the country.

The decision was made on the grounds that Glivec is not a new medicine, but an amended version of a known compound.

Indian law bans firms from making patients pay higher prices for medicines by making slight changes to a compound, a practice known as “evergreening”.

The Supreme Court said Glivec does not satisfy a patent’s “novelty” requirement, Pravin Anand, lawyer for Novartis, told reporters.

By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.

A ‘blow’ for Novartis

“It’s a blow for the Swiss lab [Novartis], because it opens access to a promising anti-cancer treatment for [Indian] populations that are far less rich,” explained Grégoire Queinnec, FRANCE 24’s correspondent in New Delhi.

The Supreme Court’s decision comes after a legal battle that began when Novartis was denied a patent for Glivec in 2006.

Among the chief beneficiaries of Monday’s ruling will be India’s Cipla Ltd and Natco Pharma Ltd, which already sell “generic” Glivec in India that costs around one-tenth of the branded drug.

Healthcare activists have long called on the government to make medicines cheaper in a country where many patented drugs are unaffordable for most of its 1.2 billion people, 40 percent of whom earn less than $1.25 a day.

Over 16,000 patients in India use Glivec, the vast majority of whom receive it free of charge, Novartis says.

By contrast, generic Glivec is used by more than 300,000 patients, according to industry reports.

Shares in Novartis’ Indian unit fell as much as 6.8 percent after the verdict, while Natco Pharma were up nearly 11 percent and Cipla up 2.5 percent, outperforming the benchmark Mumbai market, which ticked up 0.1 percent.

India’s domestic drugs market is the 14th largest globally, but with annual growth of 13-14 percent and the world’s second-biggest population, international pharmaceutical firms say it has massive potential at a time when traditional developed markets have slowed down.

A precedent that sets up obstacles for patents

Pfizer’s cancer drug Sutent and Roche’s hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed.

The Supreme Court’s ruling on Glivec will make it tougher for them to win back patent protection.

Novartis has previously said it needs legal certainty if it is to plan further investment in drug research in India.

The Swiss drugmaker has been fighting since 2006 to win a patent for an amended form of Glivec.

In 2009 it took its challenge against the law banning patents on newer but not radically different forms of known drugs to the Supreme Court.